Device and method for implanting a spinous process fixation device

ABSTRACT

The disclosure provides a device to facilitate the insertion and attachment of an implant that includes a barrel assembly and a plate assembly in an interspinous space. The device comprises a main body, a first arm that is configured to hold the barrel assembly, and a second arm that is configured to hold a locking plate of the plate assembly, wherein the first and second arms are movably attached to the main body.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.13/466,228 filed on May 8, 2012 which is incorporated in its entiretyherein.

BACKGROUND OF THE PRESENT DISCLOSURE

1. Field of the Present Disclosure

The present disclosure is generally directed to a surgical device thatmay be used to, e.g., insert and attach (or remove and extract) aspinous process fixation device.

2. Related Art

A spine comprises vertebrae which are a series of small bones, and alsoincludes spinous processes. A spinous process is one of two bonyprotrusions arising from the posterior side of each vertebra in thehuman spine. Extending backwards and downwards from the main body of thevertebra, each spinous process is an extension of the lamina. Thelaminae are two bony plates that converge at the back of each vertebrato form the vertebral arch. The spinous processes curve outward fromthis junction. A variety of scenarios may exist where damage to thespine may occur including, but not limited to, injury or illness.Severe, even debilitating, pain can result from such damage. In someinstances, artificial assistance may be necessary to address suchdamage.

Surgical procedures exist that attempt to address such damage includingusing various vertebral fixation devices. Conventional devices exist toimplant vertebrae fixation devices, but such devices often suffer fromthe problem of being purely manual and are usually complex. Such manualdevices require the use of human muscle, which can fatigue, to performthe procedure. Moreover, the incision opening for insertion of thesefixation devices may require substantial openings to achieve access tothe spinous process.

Accordingly, there is a need for a surgical device that improves andsimplifies a surgeon's ability to insert (or remove) a spinous processfixation device in (from) a patient.

SUMMARY OF THE PRESENT DISCLOSURE

The present disclosure meets the foregoing need of improving andsimplifying a surgeon's ability to insert (or remove) a spinous processfixation device. The surgical device, according to the presentdisclosure, comprises a posterior, non-pedicle supplemental fixationdevice that may be implemented, for example, to insert and attach (orremove and extract) a fixation device in a non-cervical spine. Duringimplementation, the surgical device preserves a supraspinous ligament,attaching firmly to the spinous processes above and below aninterspinous space. The fixation device is constructed to withstand thecompressive, torsional, and shear loads that can be found in the lumbarspine.

Accordingly, one aspect of the present disclosure provides a device tofacilitate the insertion and attachment of an implant that includes abarrel assembly and a plate assembly in an interspinous space. Thedevice comprises a main body, a first arm that is configured to hold thebarrel assembly, and a second arm that is configured to hold a lockingplate of the plate assembly, wherein the first and second arms aremovably attached to the main body.

Additional features, advantages, and aspects of the present disclosuremay be set forth or apparent from consideration of the followingdetailed description, drawings, and claims. Moreover, it is to beunderstood that both the foregoing summary of the present disclosure andthe following detailed description are exemplary and intended to providefurther explanation without limiting the scope of the present disclosureas claimed.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are included to provide a furtherunderstanding of the present disclosure, are incorporated in andconstitute a part of this specification, illustrate aspects of thepresent disclosure and together with the detailed description serve toexplain the principles of the present disclosure. No attempt is made toshow structural details of the present disclosure in more detail thanmay be necessary for a fundamental understanding of the presentdisclosure and the various ways in which it may be practiced. In thedrawings:

FIG. 1A shows an example of a spinous process fixation device that maybe used with a surgical device that is constructed according to theprinciples of the disclosure;

FIG. 1B shows a perspective view of a barrel assembly of the spinousprocess fixation device of FIG. 1A;

FIG. 2A shows a front view of an example of the surgical device in afirst operable position;

FIG. 2B shows a side view of the surgical device of FIG. 2A;

FIG. 2C shows a rear view of the surgical device of FIG. 2A;

FIG. 2D shows a perspective side view of the surgical device of FIG. 2A;

FIGS. 3A-3D correspond to FIGS. 2A-2D, except that the surgical deviceis configured in a second operable position;

FIGS. 4A-4D correspond to FIGS. 2A-2D, except the surgical device isconfigured in a third operable position;

FIG. 5A shows the surgical device in the fourth operable position,without an implant;

FIG. 5B shows a cross-section cut view of the surgical device of FIG.5A;

FIG. 5C shows the surgical device in the fourth operable position, afteran actuator is adjusted;

FIG. 5D shows a cross-section cut view of the surgical device of FIG.5C, taken along a vertical axis, showing internal mechanisms;

FIG. 6A shows the surgical device in the third operable position, aftera release lever is opened; and

FIG. 6B shows a cross-section cut view of the surgical device of FIG.6A.

DETAILED DESCRIPTION OF THE PRESENT DISCLOSURE

The aspects of the present disclosure and the various features andadvantageous details thereof are explained more fully with reference tothe non-limiting aspects and examples that are described and/orillustrated in the accompanying drawings and detailed in the followingdescription. It should be noted that the features illustrated in thedrawings are not necessarily drawn to scale, and features of one aspectmay be employed with other aspects as the skilled artisan wouldrecognize, even if not explicitly stated herein. Descriptions ofwell-known components and processing techniques may be omitted so as tonot unnecessarily obscure the aspects of the present disclosure. Theexamples used herein are intended merely to facilitate an understandingof ways in which the present disclosure may be practiced and to furtherenable those of skill in the art to practice the aspects of the presentdisclosure. Accordingly, the examples and aspects herein should not beconstrued as limiting the scope of the present disclosure, which isdefined solely by the appended claims and applicable law. Moreover, itis noted that like reference numerals represent similar parts throughoutthe several views of the drawings.

The present disclosure is generally directed to a surgical device. Morespecifically, the disclosure may be directed to a device, used by asurgeon, to facilitate the insertion and attachment (or removal andextraction) of a spinous process fixation device above and below aninterspinous space, while preserving the supraspinous ligament. Thespinous process fixation device (or implant) may comprise, but is notlimited to, for example, a SP-FIX™ spinous process fixation system,which is manufactured by Globus Medical, Inc., or similar devices.

The word “surgeon,” as used in this disclosure, means any person thatuses the disclosure to either sever tissue or attempt to sever tissue.Such a person may be educated, certified, and trained to performsurgical procedures involving the removal of tissue. Such a person mayalso be a lay person with no experience in the surgical field. Inaddition, such a person may have a skill-set, education, and/orknowledge base which falls somewhere between a person who may beeducated, certified, and trained to perform surgical procedures and alay person.

Surgical intervention for back pain is usually reserved for people withchronic back pain, perhaps for which other treatments have failed.Surgery may be required for people who have, for example, chronic lowerback pain and sciatica (often diagnosed with a herniated disc), spinalstenosis, spondylolisthesis (vertebra of the lumbar spine slips out ofplace), or vertebral fractures with nerve involvement. Also, surgery maybe necessary for people with discogenic lower back pain (e.g.,degenerative disc disease) that may occur as part of the aging process.In these situations, among others, implants may be included in a courseof treatment. Generally, the goal may be to achieve supplemental fusion.

FIG. 1A shows an example of an implant 1 that may be used with asurgical device that is constructed according to the principles of thedisclosure. The implant 1 may comprise a barrel assembly 2, 3, and aplate assembly 4, 5. The barrel assembly 2, 3 may include a barrel body2 and an integrated central ratcheting rod 3. The barrel body mayinclude a pair of extensions 21, 22 that form a mouth 23 of the barrelbody 2 at one end. The barrel body 2 may include a pair of pockets 24 atan end of the pair of extensions 21, 22 that is opposite the mouth 23.The central ratcheting rod 3 may be inserted through the end oppositethe mouth 23 and positioned between the extensions 21, 22. The plateassembly may include a pivoting plate 4 and a locking plate 5. Thelocking plate 5 may include a pair of support openings 52, 54.

FIG. 1B shows a perspective view of the barrel assembly 2, 3 of theimplant 1.

FIGS. 2A-6B show various views of an example of a surgical device 10 ina first operable position, constructed according to the principles ofthe disclosure. In particular, FIG. 2A shows a front view of thesurgical device 10 in a first operable position; FIG. 2B shows a sideview of the surgical device 10; FIG. 2C shows a rear view of thesurgical device 10; FIG. 2D shows a perspective side view of thesurgical device 10; FIGS. 3A-3D correspond to FIGS. 2A-2D, except thatthe surgical device 10 is configured in a second operable position;FIGS. 4A-4D correspond to FIGS. 2A-2D, except the surgical device 10 isconfigured in a fourth operable position; FIG. 5A shows the surgicaldevice 10 in the third operable position, without an implant; FIG. 5Bshows a cross-section cut view of the surgical device 10 of FIG. 5A;FIG. 5C shows the surgical device 10 in the third operable position,after an actuator is adjusted; FIG. 5D shows a cross-section cut view ofthe surgical device 10 of FIG. 5C, taken along a vertical axis, showinginternal mechanisms; FIG. 6A shows the surgical device 10 in the thirdoperable position, after a release lever is opened; and FIG. 6B shows across-section cut view of the surgical device 10 of FIG. 6A. Thesurgical device 10 is configured as a single instrument that may be usedto insert (or extract) and attach an implant firmly to the spinousprocesses above and below an interspinous space, while immobilizing alumbar motion segment posteriorly.

Referring to FIG. 3D, the surgical device 10 consists of a singleinstrument that comprises a main body 100 and a pair of arms 200, 300.The main body 100 may include a handle portion 110 and an arm supportportion 120.

The handle portion 110 is configured to be easily grasped and held by,for example, at least one hand. The handle portion 110 may have asubstantially cylindrical shape. The handle portion 110 may beergonomically designed for better fit and comfort in a surgeon's hand.The handle portion 110 may include an opening 115 to reduce the weightof the overall surgical device 10, as well as to allow the surgeon tosee through the surgical device 10 during operation. The opening 115 mayalso be used for storage, allowing the surgical device 10 to be placed,for example, on a tool support (not shown) through the opening 115. Thehandle portion 110 may further include a pair of cutaway portions 117,each of which is configured to receive an upper portion of the arms 200,300, thereby providing a compact, portable, and secure overallconfiguration of the surgical device 10 when, for example, it is not inuse. This configuration will also help to keep the arms 200, 300 inproper alignment with each other, as well as with the arm supportportion 120.

The arm support portion 120 is configured to movably support the arms200, 300, allowing each arm to move independently of the other arm. Thearm support portion 120 may include a plurality of fasteners 122, 124,each of which may be configured to engage and movably hold an end of arespective cross-arm 422 (432), 424 (434). For example, the fastener 122may be configured to engage and hold an end of each of the cross-arms422, 432, the other ends of which may be movably attached to the arms200, 300, respectively. Similarly, the fastener 124 may be configured toengage and hold an end of each of the cross-arms 424, 434, the otherends of which may be movably attached to the arms 200, 300,respectively. The fasteners 122, 124 may include, but are not limitedto, for example, a pin, a rod, a screw, a bolt, a rivet, a nut, ac-clip, a u-clip, a clip, a washer, or the like.

The arm support portion 120 may include one or more cavities 125 thatare designed to receive the cross-members 422, 432, 424, 434, so thatthe arm support portion 120 and arms 200, 300 may be compacted to aconfiguration of the surgical device 10 that has minimal dimensions whenit is in a closed position (e.g., shown in FIGS. 4B and 4D). Thecavities 125 may also serve to reduce the overall weight and/or cost ofthe surgical device 10, as less material may be used to manufacture thearm support portions 120.

The arm support portion 120 may further include a plurality of recesses126, each of which is configured to receive a corresponding projection226 or projection 326. When the surgical device 10 is in its fullycompacted configuration (not shown), the projections 226, 326 align withand engage corresponding recesses 126 to provide a very compact overallsize for the arm support portion 120, which ensures secure alignment ofthe arms 200, 300 and arm support portion 120 for longevity and optimalperformance.

The arm 200 may comprise an actuator 210, an arm body 220, an implementholder 240, and a release lever 270. The actuator 210 may include, butis not limited to, a dial, a lever, a knob, a screw, a bolt, a wing-nut,or the like. The actuator 210 may further include, for example, a cam.The arm body 220 may include a plurality of openings 225 and a channel280 (shown in FIG. 5B).

Referring to FIG. 5B, the actuator 210 may be operationally coupled toone end of a longitudinal grip member 250. The actuator 210 may befurther coupled to a longitudinal guide member 260. The longitudinalgrip member 250 and the longitudinal guide member 260 may be located inthe channel (or recess) 280 provided in the arm body 220. Thelongitudinal grip member 250 may include a gripper 244 at the endopposite the end proximal to the actuator 210. The gripper 244 makes upa portion of the holder 240.

In the example shown in FIG. 5B, the actuator 210 comprises a dial thatis attached to a cam 215, so that when the dial is manipulated, the cam215 rotates, forcing the longitudinal grip member 250 to move (e.g.,up/down) along the longitudinal axis of the arm 200, thereby driving thegripper 244 to move (e.g., up/down) along the longitudinal axis of thearm 200. The actuator 210 and the longitudinal grip member 250 may beoperationally attached to the longitudinal member 260, which may beattached to the release lever 270, such that when the release lever 270is operated, the entire gripper assembly moves (e.g., up/down) along thelongitudinal axis. The gripper assembly may include the actuator 210,the longitudinal grip member 250, and the gripper 244.

The holder 240 comprises the gripper 244 and an associated gripper 242.The associated gripper 242 may be integrally formed with the arm body220, or provided as a separate component (not shown) that may besecurely affixed to the arm body 220.

The release lever 270 may be attached to the arm body 220 and/or thegripper assembly. The release member 270 may be configured to drive thegripper assembly to cause the gripper 244 to move (e.g., up/down) alongthe longitudinal axis of the arm 200. For instance, the release lever270 may be configured to engage the entire gripper assembly, so as tomove the gripper assembly along the longitudinal axis. Referring toFIGS. 5A and 6A, the actuator 210 is shown as being in a first positionin FIG. 5A, prior to the release lever 270 being manipulated to releasethe gripper 244, and in a second position in FIG. 6A, after the releaselever 270 is manipulated to cause the gripper 244 to move (e.g., down)along the longitudinal axis, thereby widening the gripping area of theholder 240.

Referring to FIGS. 3D and 5B, the arm 300 may comprise an arm body 320,a holder 340, and a release lever 370. The arm body 320 may include aplurality of openings 325 and a channel 380.

The release lever 370 may be operationally coupled to one end of alongitudinal plate grip member 350. The longitudinal plate grip member350 may be located in the channel (or recess) 380 provided in the armbody 320. The longitudinal plate grip member 350 may include a plategripper 344 at the end opposite to the end proximal to the release lever370. The longitudinal plate grip member 350 may be configured to move(e.g., up/down) along the longitudinal axis of the arm 300, therebydriving the plate gripper 344 to move (e.g., up/down) along thelongitudinal axis of the arm 300. The plate gripper 344 makes up aportion of the holder 340. The longitudinal plate grip member 350 may beformed as a single piece, or from multiple pieces that may be assembledinto a single piece. The longitudinal plate grip member 350 may beintegrally formed with the plate gripper 344.

In the example shown in FIG. 5B, the release lever 370 may beoperationally coupled to the longitudinal plate grip member 350 via, forexample, a plurality of fasteners 372, 376 and a release member 374. Thefasteners 372, 376 may include, but are not limited to, for example, apin, a rod, a screw, a bolt, a rivet, a nut, a c-clip, a u-clip, a clip,a washer, a weld, or the like. The release member 374 may be made of astrong, resilient material (e.g., a metal, a plastic, or the like) thatmay bend when pressed by a lever member 378, thereby storing potentialenergy. When the lever 370 is released (e.g., lifted up), the levermember 378 is retracted, allowing the release member 374 to release thepotential energy stored therein, straightening in the process to causethe longitudinal plate grip member 350 and the plate gripper 344 to move(e.g., down) along the longitudinal axis to widen the grip area of theholder 340.

The holder 340 comprises the plate gripper 344 and an associated plategripper 342. The holder 340 further comprises a pair of plate supportmembers 346, 348 (shown in FIG. 2C), which are configured to be insertedinto the support openings 52, 54 of the locking plate 5, to ensureproper alignment of the locking plate 5 with the pivoting plate 4 whenthe implant is installed. The support members 346, 348 may be integrallyformed with, or attached to each end of a u-shape portion 349 of theholder 340. The u-shape portion 349 includes an opening 345 to allow theextension 21 (or 22) of the barrel body 2 to pass there-through duringinstallation of the implant 1. The associated plate gripper 342 may beintegrally formed with the arm body 320, or provided as a separatecomponent (not shown) that may be securely affixed to the arm body 320.

The release lever 370 may be attached to the arm body 320, andpositioned so that the lever 378 may engage and bend the release member379 when the lever 370 is engaged (e.g., shown in FIG. 5B), andsubstantially disengage and allow the release member 347 to cause thelongitudinal plate grip member 350 to move (e.g., down) along thelongitudinal axis, by, for example, straightening.

Referring to FIGS. 1A and 2A-2D, the arm 200 may be moved (e.g.,downward) to its fully deployed (or extended) length along itslongitudinal axis with respect to the arm support portion 120. The arm300 may be kept in (or moved to) its compact position (e.g., shown inFIG. 2B), so as to keep it out of the way while a barrel assembly 2, 3and pivoting plate 4 are loaded into the holder 240 of the arm 200. Therelease lever 270 may be released (or disengaged), thereby expanding thewidth of the grip area of the holder 240—i.e., the distance between thegripper 244 and the associated gripper 242. An end of a barrel assembly2, 3 (with the pivoting plate 4) of an implant may be positioned in theholder 240 and the release lever 270 may be engaged, causing the gripper244 to move (e.g., up) along the longitudinal axis of the arm 200 toengage a pocket 24 of the barrel body 2 and drive the other pocket 24 ofthe barrel body 2 in the same direction against the associated gripper242, so that the barrel assembly 2, 3 (and pivoting plate 4) is securelynested in the holder 240. The pivoting plate 4 may have been previouslyloaded into the barely assembly 2, 3 by turning the central ratchetingrod 3 to draw the pivoting assembly completely into the barrel body 2.

Prior to, or after the barrel assembly 2, 3 and pivoting plate 4 arenested in the holder 240, the arm 300 may be moved (e.g., downward)along its longitudinal axis with respect to the arm support portion 120.The arm 200 may be kept in (or moved to) its compact position (notshown), so as to keep it out of the way while a lock plate 5 is loadedinto the holder 340 of the arm 300. The release lever 370 may bereleased (or disengaged), thereby expanding the width of the grip areaof the holder 340—i.e., the distance between the plate gripper 344 andthe associated plate gripper 342. An end of the locking plate 5 may bepositioned and mounted onto to the plate support members 346, 348 of theholder 340 and the release lever 370 may be engaged, causing the plategripper 344 to move (e.g., up) along the longitudinal axis of the arm300 to engage a portion (e.g., a lower portion) of the locking plate 5and drive another portion (e.g. an upper portion) of the locking plate 5in the same direction against the associated plate gripper 342, so thatthe locking plate 5 is securely nested in the holder 340.

After the barrel assembly 2, 3 and pivoting plate 4 have been securelyloaded and nested in the holder 240, and the locking plate 5 has beensecurely loaded and nested in the holder 340, the barrel assembly 2, 3and pivoting plate 4 may be inserted in an interspinous space between apair of spinous processes.

Referring to FIG. 2B, the arm 200 may be extended along its longitudinalaxis to its fully extended length. The holder 240, including the nestedbarrel assembly 2, 3 and pivoting plate 4 may be inserted through anopening and positioned proximate an interspinous space that is to betreated. After proper alignment, the barrel assembly 2, 3 and pivotingplate 4 may be inserted into the interspinous space.

Referring to FIG. 3D, the arm 200 may be extended in a direction that issubstantially perpendicular to its longitudinal axis with respect to thearm support portion 120. Simultaneously, or subsequently, the arm 300may be extended along its longitudinal axis to its full extended length.The holder 340, including the lock plate 5 may be inserted through theopening and positioned in alignment with the barrel assembly 2, 3 andpivoting plate 4, as seen in FIG. 3D. The actuator 210 may bemanipulated to cause the pockets 24 of the barrel body 2 to be squeezedtoward each other, thereby causing the extensions 21, 22 to move awayfrom each other, widening the mouth 23 opening of the barrel body 2, asdiscussed above, thereby allowing for the lock plate 5 to be squeezedinto the mouth of the barrel 2 until it engages the upper and lowerspinous processes surrounding the interspionous space that is beingtreated. The arms 200 and 300 may be squeezed toward each other, therebydriving the plates 4, 5 against the upper and lower spinous processesand firmly attaching the plates 4, 5 to the spinous processes. Theactuator 210 may then be manipulated to close the mouth 23 of the barrelbody 2, thereby engaging and locking the locking plate 5 into positionwith regard to the barrel assembly 2, 3, the pivoting plate 4, and theupper and lower spinous processes. The release levers 270, 370 may bedisengaged (or released) to release the implant 1. After the implant 1has been released, the arms 200, 300 may be expanded to allow theholders 240, 340 to clear the implant 1 and to be removed from thesurgical area.

An implant 1 may be removed from a patient by repeating the foregoingsteps in a reverse order.

While the present disclosure has been described in terms of exemplaryaspects, those skilled in the art will recognize that the presentdisclosure can be practiced with modifications in the spirit and scopeof the appended claims. These examples given above are merelyillustrative and are not meant to be an exhaustive list of all possibledesigns, aspects, applications or modifications of the presentdisclosure.

What is claimed is:
 1. A method for installing an implant in aninterspinous space, the method comprising: providing an instrumentcomprising: a main body; a first arm; and a second arm, wherein thefirst arm comprises a gripper and an associated gripper, wherein thefirst and second arms are movably attached to the main body wherein thefirst and second arms are movably coupled to the main body andconfigured to be moved along a longitudinal axis of the main body; andinstalling the implant in the interspinous space using the instrument.2. The method of claim 1, wherein the first arm further comprises: alongitudinal grip member that is operationally coupled between a holderand an actuator.
 3. The method of claim 1, further comprises providingbone graft material around the implant.
 4. A method for installing animplant that includes a barrel assembly and a plate assembly in aninterspinous space, the device comprising: providing an instrumentcomprising: a main body; a first arm that is configured to hold thebarrel assembly; and a second arm that is configured to hold a lockingplate of the plate assembly, wherein the first arm comprises a gripperand an associated gripper, wherein the gripper and the associatedgripper extend laterally in a direction toward the second arm, whereinthe first and second arms are movably attached to the main body, whereinthe first and second arms are movably coupled to the main body andconfigured to be moved along a longitudinal axis of the main body; andinstalling the implant in the interspinous space using the instrument.5. The method of claim 4, wherein the main body comprises: a handleportion that is configure to be held by at least one hand; and an armsupport portion that is configured to movably support the first arm andthe second arm.
 6. The method of claim 4, wherein at least one of thefirst arm and second arm comprise a release lever.
 7. The method ofclaim 4, further comprising a holder that is configured to compress apair of ends of a barrel body of the barrel assembly under operationalcontrol of an actuator.
 8. The method of claim 7, wherein the gripper isoperationally coupled to the actuator.
 9. The method of claim 8, whereinthe first arm comprises: a longitudinal grip member that isoperationally coupled between the actuator and the gripper.
 10. Themethod of claim 9, further comprising: a release lever operationallycoupled to the actuator and the gripper.
 11. The method of claim 4,further comprising: a first cross-arm that is movably coupled betweenthe first arm and the main body.
 12. The method of claim 11, furthercomprising: a second cross-arm that is movably coupled between thesecond arm and the main body.
 13. The method of claim 12, wherein thefirst and second cross-arms are movably coupled to the main body by asingle fastener.
 14. The method of claim 4, wherein the second armcomprises: a plate gripper that is configured to engage a portion of thelocking plate.
 15. The method of claim 14, further comprising: a releaselever operationally coupled to the plate gripper, wherein the releaselever is configured to release the plate gripper when it is disengaged.16. The method of claim 14, wherein the second arm comprises: a holderthat is configured to receive and hold the locking plate.
 17. The methodof claim 16, wherein the holder comprises a plate support member. 18.The method of claim 4, wherein the first and second arms are configuredto independently move along a longitudinal axis of the main body. 19.The method of claim 18, wherein the first and second arms are furtherconfigured to independently move along an axis that is substantiallyperpendicular to the longitudinal axis of the main body.